Methods to reduce body fat

ABSTRACT

The invention provides methods and compositions for reducing the percentage of body fat in a mammal and/or the level of leptin in the bloodstream of the mammal. Such methods involve administering to the mammal a diet containing viscous polysaccharides.

FIELD OF THE INVENTION

[0001] The present invention relates to the use of non-nutritive,viscous polysaccharides to reduce the percentage of body fat and thelevel of leptin in mammals. Examples of such polysaccharides includewater-soluble cellulose-like polysaccharides such as β-glucans andhydroxypropyl methylcellulose.

BACKGROUND OF THE INVENTION

[0002] Obesity affects an ever-increasing proportion of the populationof Western cultures. Nearly one-third of adults in the United States arein excess of their ideal body weight by at least 20%. Obesity has becomea major public health problem, at least in part because it is associatedwith other health problems such as hypertension, elevated blood lipids,coronary artery disease, osteoarthritis and Type II ornon-insulin-dependent diabetes mellitus (NIDDM). In the United Statesalone, there are an estimated 6-10 million individuals with NIDDM,including 18% of the population over 65 years of age and most of theseindividuals are obese (Harris et al. Diabetes 36:523-534, 1987).

[0003] According to conventional wisdom, stability in body compositionrequires that energy intake equals expenditure, at least over aprolonged period of time. Such wisdom therefore requires that obesepersons reduce their food intake in order to reduce their weight andtheir percent body fat. However, while reduction of caloric intake canlead to short-term weight loss, the lost weight is often regained.Moreover, some evidence indicates that prolonged fluctuation of bodyweight can lead to weight increases and to increased body fat content.

[0004] It appears that there may be a signaling system that adjustsappetite, and accordingly food intake, to preserve a constant totaladipose tissue mass. The nature of this signaling system has beenexamined in a variety of animal experiments involving induced weightchange (Cohn et al., Yale J. Biol. Med. 34:598-607, 1962; Harris et al.,Proc. Soc. Exp. Biol. Med. 191:82-89, 1989; and Wilson et al., Am. J.Physiol. 259: R1148-R1155, 1990); lipectomy (Forger et al., Metabolism37:782-86, 1988; Liebelt et al., Ann. N.Y. Acad. Sci. 131:559-82, 1965;and Chlouverakis et al., Metabolism 23:133-37, 1974); plasma transferfrom obese or satiated animals to hungry animals (Davis et al., Science156:1247-48, 1967; Davis et al., J. Comp. Physiol. Psychol. 67:407-14,1969; and King, Physiol. Psychol. 4:405-08, 1976); and parabiosisbetween obese and lean animals (Hervey, J. Physiol. 145:336-52, 1959;Parameswaran et al., Am. J. Physiol. 232:R150-R157, 1977; Nishizawa etal., Am. J. Physiol. 239:R344-351, 1980; Harris et al., Am. J. Physiol.257: R326-R336, 1989; Schmidt et al., Acta Physiol. Acad. Sci. Hung.Tomus 36:293-98, 1969; Coleman et al., Diabetologia 9:294-98, 1973;Harris et al., Int. J. Obesity 11:275-83, 1987; and Coleman et al., Am.J. Physiol. 217:1298-1304, 1969).

[0005] Such studies may have identified certain factors that areinvolved in regulating obesity and body fat content, but confusionexists as to how to use such information to treat obesity. For example,Fried et al., 130 J. Nutr. 3127S-3131S (2000) has disclosed that serumleptin levels are usually elevated in obesity, indicating that lowerserum levels of leptin may be beneficial for treating obesity. However,earlier animal data indicated that a leptin deficiency might lead toobesity. Mice that have homozygous mutant ob genes (ob/ob) have beenreported to be obese but when given daily injections of recombinantleptin, their food intake was markedly inhibited and they experienced areduction in body weight and fat. It is known that leptin is a proteinexpressed by the ob gene and that it is secreted by adipose tissue. Someresearches have provided data indicating that leptin is a satiety factorand a regulator of metabolism (Levin et al., 1996 Proc. Natl Acad. Sci.USA 93:1726-1730). Hence, the relationship between leptin levels andbody fat has been contradictory. See also, Pelleymounter et al., 1995,Science 269:540-543; Halaas et al., 1995 Science 269: 543-546; andCampfield et al., 1995 Science 269:546-549.

[0006] A number of studies have been conducted on the role of dietaryfiber in health and disease. Some studies comparing the effects ofvarious fiber sources on cholesterol have concluded that solublecellulose-like materials reduce cholesterol levels. For example, U.S.Pat. Nos. 5,585,366 and 5,721,221 to Gallaher et al. disclose methodsfor reducing cholesterol levels in mammalian blood by administering highviscosity water-soluble cellulose derivatives such as hydroxypropylmethylcellulose. U.S. Pat. No. 6,020,324 to Jamas et al. disclosesdietary supplements containing intact whole β-glucan in an amountsufficient to lower serum cholesterol levels. However, these patents donot provide treatments for reducing body fat.

[0007] Current weight loss treatment regimens generally either havenegative side effects or are not particularly effective. Accordingly, anew approach is needed to regulating body fat content.

SUMMARY OF THE INVENTION

[0008] The invention provides methods and compositions for reducing thepercentage of body fat in a mammal and the level of leptin in thebloodstream of a mammal comprising administering a sufficient amount ofviscous, water-soluble, non-nutritive, non-starch, indigestiblepolysaccharide to the mammal for a time sufficient to reduce thepercentage of body fat in the mammal. Such polysaccharides are polymersof monosaccharides substantially connected by beta (β) glycosidiclinkages. The monosaccharides can be arabinose, fructose, glucose,glucosamine, glucuronic acid, galactose, galactosammine, mannose,N-acetylmuramic acid, N-acetylneuraminic acid, rhamnose, xylose or amixture thereof. The beta glycosidic linkages are 1→2 beta-glycosidicbonds, 1→3 beta-glycosidic bonds, 1→4 beta-glycosidic bonds, 1→6beta-glycosidic or a mixture thereof Examples of polysaccharidescontemplated by the invention include locust bean gum, guar gum,carrageenan, alginate, modified cellulose, beta-glucan, or glucomannan.

[0009] In one embodiment, the polysaccharide has Formula I:

[0010] wherein

[0011] each R is separately hydroxy, lower alkyloxy, or hydroxy(lower(alkyloxy));

[0012] n is an integer ranging from about 500 to about 2500; and

[0013] X is an R group or a covalent bond to the oxygen at the firstposition of the adjacent monosaccharide.

[0014] Such polysaccharides can also be methylcellulose, hydroxypropylmethylcellulose, 2-hydroxypropyl methylcellulose, 2-hydroxyethylmethylcellulose, 2-hydroxybutyl methylcellulose, 2-hydroxyethylethylcellulose, 2-hydroxypropyl cellulose, methyl ethylcellulose, or2-hydroxyethylcellulose.

[0015] Preferred polysaccharides are β-glucan and hydroxypropylmethylcellulose.

[0016] The compositions and polysaccharides of the invention can beadministered or incorporated into a foodstuff. For example, thecompositions and polysaccharides of the invention can be administered orincorporated into the an applesauce, a cereal, a cookie, a cracker, aflavored drink, a fruit juice, an ice cream, a milk shake, a pudding ora snack bar.

[0017] An example of a sufficient amount of polysaccharide is an amountthat provides an intestinal viscosity of about 1000 mPa·s to about 3000mPa·s, preferably about 1500 mPa·s to about 2500 mPa·s.

[0018] An example of a sufficient amount of polysaccharide to beadministered or consumed is about 1 g to about 5 g polysaccharide permeal, preferably about 2 g to about 3 g polysaccharide per meal. A timesufficient for reducing the percentage of body fat is at least about twoto at least about ten weeks, preferably at least about three weeks to atleast about eight weeks, more preferably at least about four to at leastabout six weeks. However, the polysaccharide or composition thereof canbe administered indefinitely.

[0019] In one embodiment, the percentage of body fat is reduced by about5% to about 40%, preferably 10% to about 30%, more preferably about 15%to about 25%.

DESCRIPTION OF THE FIGURES

[0020]FIG. 1 graphically illustrates the relationship between thepercent of fat mass and the viscosity of a supernatant of the intestinalcontents of rats. As illustrated, there is a negative correlationbetween the intestinal viscosity and the percent fat mass, indicatingthat percent body fat decreases as the viscosity of the diet increases.

[0021]FIG. 2 graphically illustrates the relationship between plasmaleptin concentration and the viscosity of a supernatant of theintestinal contents of rats. As illustrated, there is a negativecorrelation between the intestinal viscosity and the concentration ofleptin in the plasma, indicating that leptin concentration decreases asthe viscosity of the diet increases.

[0022]FIG. 3 graphically illustrates the relationship between plasmaleptin concentration and the viscosity of a supernatant of theintestinal contents of rats. As illustrated, there is a negativecorrelation between the intestinal viscosity and the concentration ofleptin in the plasma, indicating that leptin concentration decreases asthe viscosity of the diet increases.

[0023]FIG. 4 graphically illustrates the relationship between plasmaleptin concentration and the percent fat pads of body weight of rats. Asillustrated, there is a positive correlation between percent fat and theconcentration of leptin in the plasma, indicating that lower leptinconcentrations are correlated with lower body fat.

[0024]FIG. 5 graphically illustrates the relationship between plasmaleptin concentration and the percent epididymal fat of body weight ofrats, after correction for body weight. As illustrated, there is apositive correlation between the percent epididymal fat and theconcentration of leptin in the plasma, indicating that body fatincreases as leptin concentration increases.

[0025]FIG. 6 is a bar graph illustrating the relationship between plasmaleptin concentration and the type of diet, before and after correctionfor body weight. The five diet types differed only in the type ofpolysaccharide fiber added: Cellulose (CE, control diet); Beta-Trim(beta glucan) low viscosity (BT-LV); Beta-Trim (beta glucan) highviscosity (BT-HV); Hydroxypropyl methylcellulose (HPMC) low viscosity(HPMC-LV); and Hydroxy-propyl methylcellulose (HPMC) high viscosity(HPMC-LV). As illustrated, the high and low viscosity HPMC diets lead tolower concentrations of leptin in the plasma.

[0026]FIG. 7 is a bar graph illustrating the relationship betweenretroperitoneal fat pad weight and the type of diet. The five diet typesdiffered only in the type of polysaccharide fiber added: Cellulose (CE,control diet); Beta-Trim (beta glucan) low viscosity (BT-LV); Beta-Trim(beta glucan) high viscosity (BT-HV); Hydroxypropyl methylcellulose(HPMC) low viscosity (HPMC-LV); and Hydroxy-propyl methylcellulose(HPMC) high viscosity (HPMC-LV). As illustrated, the high viscosityBeta-Trim (beta glucan) diet and the high and low viscosity HPMC dietslead to lower retroperitoneal body fat.

DETAILED DESCRIPTION OF THE INVENTION

[0027] The present invention provides methods and compositions forreducing the percentage of body fat and/or the serum levels of leptin ina mammal by administering a viscous polysaccharide. In general, theviscous polysaccharides of the invention are water-soluble,non-nutritive, non-starch-like and indigestible. High viscositypolysaccharides are often very useful for reducing the percentage ofbody fat and for lowering leptin levels in the blood. However, it is theviscosity of the water-soluble fraction of the intestinal contents thatis most important for achieving optimal reduction in body fat and leptinlevels. Accordingly, a lower viscosity polysaccharide can beadministered so long as the amount administered provides sufficientviscosity within the soluble portion of the intestinal contents.

[0028] Any water-soluble, non-nutritive, indigestible, non-starch,viscous polysaccharide available to one of skill in the art can be usedin the compositions and methods of the invention. The viscouspolysaccharides employed in this invention are further characterized inthat they are non-toxic, non-ionic, non-caloric, biologically inert butedible. Examples of viscous polysaccharides that can be used includelocust bean gum, guar gum, carrageenans, alginates, modified celluloses,beta-glucans, glucomannans and the like.

[0029] The viscous polysaccharides of the invention are branched ornon-branched polymers of monosaccharides. A variety of monosaccharidesubunits can be present in the viscous polysaccharides of the inventionincluding arabinose, fructose, glucose, glucosamine, glucuronic acid,galactose, galactosammine, mannose, N-acetylmuramic acid,N-acetylneuraminic acid, rhamnose, xylose and the like. Such viscouspolysaccharides can have a single type of monosaccharide subunit, e.g.only glucose, or a mixture of a variety of monosacharide subunits.

[0030] The covalent linkages connecting the monosaccharide subunits aregenerally beta (β) glycosidic linkages, although a small number of alpha(α) glycosidic linkages can be present, for example, at branch points.Examples of linkages that exist between the monosaccharides include 1→2beta-glycosidic bonds, 1→3 beta-glycosidic bonds, 1→4 beta-glycosidicbonds, 1→6 beta-glycosidic bonds.

[0031] In one embodiment, the viscous polysaccharide is a water-soluble,cellulose-like polysaccharide. Such water-soluble cellulose-likepolysaccharides include polymers of glycosides having either 1→3 or 1→4beta-glycosidic bonds, or a mixture of 1→3 and 1→4 beta-glycosidicbonds.

[0032] The cellulose-like polysaccharides used in the invention have amixture of 1→3 and 1→4 beta-glycosidic bonds and/or have only 1→3 or 1→4beta-glycosidic bonds with various substituents in place of the hydroxylgroups found on cellulose so that the cellulose-like polysaccharide issoluble in aqueous solution. Beta-glucans have mixed 1→3 and 1→4beta-glycosidic bonds and are found in natural materials such as oatsand barley.

[0033] Examples of the structures of cellulose, with 1→4 beta-glycosidicbonds, and of beta-glucan, with a mixture of 1→3 and 1→4 beta-glycosidicbonds, are provided below, where a portion of each structure isillustrated.

[0034] Cellulose is a natural beta-glycosidic polymer having 1→4beta-glycosidic bonds where substantially all of the glycosidic subunitsare substituted with hydroxyl groups. However, cellulose tends to beinsoluble in aqueous solution. Accordingly, unmodified cellulose ispreferably not used in the compositions and methods of the invention.

[0035] In contrast, the viscous polysaccharides of the invention arewater-soluble. “Water soluble” for purposes of this application meansthat 2 grams of powdered viscous polysaccharide can be dispersed bystirring into 100 grams of water at a temperature between 0° C.-100° C.to provide a substantially clear, stable aqueous composition ordispersion, when the dispersion is brought to a temperature of about 20°C.

[0036] Water-soluble cellulose-like materials with 1→4 beta-glycosidicbonds that contain lower alkyloxy or hydroxy (lower(alkyloxy))substituents can also be used in the compositions and methods of theinvention. Similarly, water-soluble cellulose-like materials with 1→3beta-glycosidic bonds, or a mixture of 1→3 and 1→4 beta-glycosidicbonds, that have lower alkyloxy or hydroxy (lower(alkyloxy))substituents can be used. Such alkyloxy substituents preferably have oneto four carbon atoms (i.e. C₁ to C₄ alkyloxy substituents). Preferredsubstituents include methoxyl and hydroxypropyloxyl groups.Cellulose-like polysaccharides with lower alkyloxy or hydroxy(lower(alkyloxy)) substituents are described in U.S. Pat. Nos.4,900,573, 4,734,285, 4,704,285, and in Kirk-Othmer-Concise Encyclopediaof Chemical Technology, M. Grayson, ed., Wiley-Interscience N.Y. (1985)at pages 231-232, the disclosures of which are incorporated herein byreference.

[0037] Representative water-soluble cellulose-like polysaccharides usedin the invention are therefore of Formula I:

[0038] where

[0039] each R is separately a hydroxy, lower alkyloxy, or hydroxy(lower(alkyloxy)) group;

[0040] n is an integer ranging from about 500 to about 2500; and

[0041] X is an R group or a covalent bond to the oxygen at the firstposition of the adjacent β-glycoside.

[0042] Many such water-soluble cellulose-like polysaccharides arecommercially available, or can be readily obtained via conventionalorganic synthetic methodology. Examples of the water-solublecellulose-like polysaccharides that can be used in the invention aremethylcellulose, hydroxypropyl methylcellulose or 2-hydroxypropylmethylcellulose, 2-hydroxyethyl methylcellulose, 2-hydroxybutylmethylcellulose, 2-hydroxyethyl ethylcellulose, 2-hydroxypropylcellulose, methyl ethylcellulose, and 2-hydroxyethylcellulose.Water-soluble β-glucan and hydroxypropyl methylcellulose are examples ofpreferred compounds for the compositions and methods of the invention. Aportion of the structure of hydroxypropyl methylcellulose is providedbelow.

[0043] The invention provides methods of reducing body fat percentagesand/or leptin serum levels in a mammal by administering to the mammal aviscous polysaccharide in an amount and for a time sufficient to reducethe percentage of body fat and/or leptin serum levels.

[0044] “Mammal” refers to any animal classified as a mammal, includinghumans, domestic and farm animals, nonhuman primates, and zoo animals,sports animals, or pet animals, such as dogs, cats, horses, cows, etc.

[0045] A time sufficient for reducing the percentage of body fat and/orleptin serum levels can vary depending on the level and duration ofintestinal viscosity achieved, the amount of viscous polysaccharideconsumed, the general health of the mammal, the level of activity of themammal and related factors. However, with routine administration orconsumption of a viscous polysaccharide of the invention, the percentageof body fat and the level of leptin in the blood generally begins todecrease within about two to about ten weeks, often within about threeweeks to about eight weeks and particularly within about four to sixweeks.

[0046] The viscous polysaccharides of the invention can be administeredor consumed indefinitely. Accordingly, there is no precise upper limiton the amount of time during which the viscous polysaccharides can beconsumed. The decision to stop consuming viscous polysaccharides cantherefore be based upon whether the desired percentage body fat and/orleptin serum levels have been reached. In general, it may be beneficialto administer or consume an appropriate amount of the viscouspolysaccharides of the invention for about twelve weeks, preferablyabout sixteen weeks, more preferably about twenty weeks. Moreover, evenwhen the desired level of body fat or serum leptin has been achieved,one may choose to continue administration or consumption of a adequateamounts of viscous polysaccharide to help maintain the desired level ofbody fat and/or leptin levels.

[0047] Accordingly, the time for administration and/or consumption ofthe viscous polysaccharides of the invention can be varied to suit theneeds of the person or mammal receiving the polysaccharides. Inparticular, because the polysaccharides of the invention are non-toxicand non-nutritive, the beneficial effects of administration can berealized by sustained or even indefinite administration or consumptionof such polysaccharides.

[0048] Although viscous polysaccharides have been used in a variety offoodstuffs to improve certain functional properties, such asemulsification, texture or moisture retention, the amounts used areusually less than 0.5% of the foodstuff. These levels are generally toolow to have a significant physiological effect on leptin levels and bodyfat percentages.

[0049] Therefore, the present invention also provides compositions andprocessed foodstuffs intended for mammalian ingestion that comprise anamount of viscous polysaccharides effective to lower the percentage ofbody fat or the amount of leptin in the bloodstream. Such compositionsor foodstuffs can be consumed alone or in combination with other foodsto meet the daily caloric requirements of the mammal. Preferably, theviscous polysaccharides of the invention are administered or consumed insufficient amounts throughout the day, rather than in a single dose oramount.

[0050] In contrast to the small amounts employed in commerciallyavailable compositions and processed foodstuffs, the compositions andfoodstuffs that are the subject of the present invention preferablycomprise about 2 to about 20 weight percentage of one or more viscouspolysaccharide, preferably about 3 to about 15 weight percentage, morepreferably about 4 to about 12 weight percentage viscouspolysaccharide(s). At these levels, about 3 g to about 20 g, preferablyabout 4 g to about 15 g, more preferably about 5 g to about 12 g, evenmore preferably about 6 g to about 10 g of viscous polysaccharides areingested daily by a large mammal such as a human.

[0051] Therefore, to achieve a useful leptin-lowering or body fatpercentage-lowering effect, an adult would ingest about 1 g to about 5 gper meal, preferably about 1.5 g to about 4 g per meal, and morepreferably about 2 g to about 3 g per meal of a viscous polysaccharide,such as a beta-glucan or hydroxypropyl methylcellulose. However, dosagescan vary and can be even higher for some human patients with highlyelevated leptin or body fat levels.

[0052] The apparent viscosity of aqueous solutions of the viscouspolysaccharides of this invention is proportional to the molecularweight or chain length of the compound. However, the average viscosityof an aqueous solution of the viscous polysaccharides of the inventionis also directly proportional to the concentration of polysaccharidepresent in the solution. Hence, the viscosity of a composition orfoodstuff can be adjusted by modulating either the molecular weight ofthe polysaccharide or the concentration of the polysaccharide.

[0053] The viscosities reported herein are measured in centipoises (cps)or centpoise (cP) or Pascal seconds (P·s) or milliPascal seconds(mPa·s), where 10 centipoise is 1 Pascal second. To obtain suchviscosity measurements, a 1 or 2% by weight aqueous solution ofpolysaccharide at 20° C. can be measured in a rotational viscometer. Theviscosity of 2% aqueous solutions of polysaccharide employed in theinvention is desirably in the range of about 50 cps to about 200,000cps, and preferably in the range of about 75 to about 100,000 cps, mostpreferably within the range of about 100 to about 10,000 cps. A “highviscosity” polysaccharide possesses a viscosity of at least 10,000 cps.

[0054] The average molecular weight of polysaccharide useful in loweringthe leptin or body fat levels in mammals is at least about 10,000daltons. If the viscosity is adjusted by modulating the molecularweight, the molecular weight can be increased. For example, themolecular weight can be increased to at least about 25,000 daltons, andpreferably at least about 50,000 daltons. In some embodiments, themolecular weight can range from about 100,000 to about 250,000 daltons.The weight average molecular weight will be 3-10 times the numberaverage molecular weight.

[0055] Many of the cellulose-like polysaccharides for use in theinvention are available to one of skill in the art. For example, HPMCcan be purchased under the trade name METHOCEL™ from Dow Chemical,Midland, Mich. Cellulose-like polysaccharides for use in the inventioncan also be made by the reaction of cellulose pulp with various chemicalreactants in the presence of caustic soda. For example, methylcellulosecan be made by reacting chloromethane with cellulose pulp and HPMC canbe made using propylene oxide and chloromethane as reactants. Forexample, see C. R. Noller, Chemistry of Organic Compounds, W. B.Saunders Co., London (2d ed. 1957) at pages 404-405.

[0056] The polysaccharides of the invention can be administered insolution or in powder form, or may be combined with other foodingredients. Preferably, the polysaccharides of the invention areadministered in combination with food or as a foodstuff. However, thepolysaccharides of the invention can also be administered aspharmaceutical compositions. Pharmaceutical compositions containing thepolysaccharides of the invention can be administered with apharmaceutically acceptable carrier in a pharmaceutical unit dosageform. Pharmaceutically acceptable carriers include tableting excipients,gelatin capsules, or carriers such as a polyethylene glycol, a naturalgel, and the like. Pharmaceutical unit dosage forms include tablets,capsules, gelatin capsules, pre-measured powders, pre-measuredsolutions, and the like. Hence, the polysaccharides may be formulated astablets, granules, capsules, suspensions and the like.

[0057] While the method of administration or consumption may vary, thepolysaccharides are preferably ingested by a human as an ingredient ofhis or her daily diet. The polysaccharides can be combined with a liquidvehicle, such as water, milk, vegetable oil, juice and the like, or withan ingestible solid or semi-solid foodstuff. A number of foodstuffs aregenerally compatible with polysaccharides of the invention. Examples ofsuch foodstuffs are disclosed by M. K. Weibel et al., U.S. Pat. No.4,923,981, the disclosure of which is incorporated by reference herein.

[0058] For example, it may be mixed into foods such as milk shakes, milkshake mixes, breakfast drinks, juices, flavored drinks, flavored drinkmixes, yogurts, puddings, ice creams, ice milks, frostings, frozenyogurts, cheesecake fillings, candy bars, including “health bars” suchas granola and fruit bars, gums, hard candy, mayonnaise, pastry fillingssuch as fruit fillings or cream fillings, cereals, breads, stuffings,dressings and instant potato mixes. An effective amount of the presentpolysaccharides can also be used as a fat-substitute in salad dressings,frostings, margarines, soups, sauces, gravies, mayonnaises, mustards andother spreads.

[0059] Therefore, “food ingredients,” as the term is used herein,includes those ingredients commonly employed in recipes for the abovefoodstuffs, including flour, oatmeal, fruits, milk, eggs, starch, soyprotein, sugar, sugar syrups, vegetable oils, butter, emulsifying agentssuch as lecithin, and the like.

[0060] The viscous polysaccharides can be partially or fully hydratedbefore they are orally ingested. For example, the viscouspolysaccharides may be dispersed in a sufficient amount of water, milk,juice, flavored water, hot chocolate, soy milk, cream, or other liquidto make a drink item that can be consumed to administer an effectiveamount of the present polysaccharides. The viscous polysaccharides maybe dispersed in a sufficient amount of water to make a syrupy liquidthat is then mixed with one or more food ingredients such as flours,oatmeal, cornmeal, rice, barley, wheat germ, and other cereal productsto made a paste or dough, the latter being subsequently treated tocreate an appealing foodstuff by procedures such as baking, extruding,and the like, to provide edible foodstuffs. Of course, colorings andflavorings may be added as may be appropriate to add to theattractiveness of the foodstuff. Food ingredients with which the viscouspolysaccharides may be combined can be metabolizable and can havepredetermined caloric values to create a diet item, diet drink or dietbar.

[0061] Therefore, in one embodiment the invention provides a compositioncomprising a food, drink or snack item, such as a cereal, milkshake orhealth bar, for reducing the percentage of body fat in a mammalcomprising functionally effective amount of a viscous polysaccharide.

[0062] In another embodiment the invention provides a compositioncomprising a food or snack item, such as a cereal or health bar, forreducing the level of leptin in the plasma of a mammal comprisingfunctionally effective amount of a viscous polysaccharide.

[0063] A functionally effective amount of viscous polysaccharide isemployed as described above.

[0064] Preferably the reduction of body fat levels is about 5% to about30%, although this amount can be varied depending on the amount andduration of administration of the viscous polysaccharide. Morepreferably, the reduction in body fat levels is about 10% to about 20%.

[0065] Leptin plasma levels can be reduced similarly. Hence, the levelof leptin in the blood can be reduced by about 5% to about 50%,preferably about 10% to about 40% and more preferably about 15% to about35%.

[0066] The desired dosage or amount of viscous polysaccharides that canbe included in the diet will vary depending on the size and sex of thehuman patient as well as the patient's leptin levels and/or percent bodyfat. For example, the foodstuffs and food items described above willtypically be formulated to comprise from about 2% to about 20% of totalpolysaccharide, depending on the viscosity grade polysaccharide used andthe type of foodstuff or food item. Combinations of concentration andviscosity would have to be determined experimentally to some extent. Forexample, in a milk shake or pudding, the weight percentage can be 10 toabout 20%. However, in baked goods, a lesser amount ranging from, forexample, about 2% to about 5% by weight, might be preferred to avoidpossible negative effects on the rheological characteristics of theproduct. Of course, the amount of viscous polysaccharide incorporatedinto a pharmaceutical unit dosage form can be much higher, since tasteand rheology are not primary considerations, e.g., from about 20-98%,preferably about 50-80% of polysaccharide can be used. For 1000 g foodthe amount of viscous polysaccharide can range from about 20 g to about200 g, preferably about 30 g to about 150 g, more preferably about 35 gto about 125 g of viscous polysaccharides are present per 1000 g food.

[0067] The present invention is further described by the followingnon-limiting examples.

EXAMPLE Viscous Polysaccharide Consumption Decreases Percent Body Fat

[0068] In this example, rats were fed a variety of diets containingdifferent types of water-soluble viscous polysaccharides. After fourweeks, rats fed high viscosity β-glucan, or either low or high viscosityhydroxypropylmethylcellulose had significantly lower body fat levels.

[0069] Materials and Methods

[0070] Animals

[0071] The animal-use protocol was approved by the University ofMinnesota Animal Care Committee. Fifty Wistar rats (initially around80-90 g) were purchased from Harlan Sprague-Dawley, Inc (Indianapolis,Ind., USA).

[0072] The rats were individually housed in wire bottom cages in atemperature controlled animal room with a daily photoperiod of twelvehours of light and twelve hours of dark, with light from 1800 to 0600.

[0073] Upon arrival, animals were fed one of the five experimental dietsfor four weeks. Body weight and 24 hour-food intake were determinedweekly for the four weeks that the experimental diets were fed.

[0074] The rats were provided the diets and water ad libitum.

[0075] Diets

[0076] The diets were all nutritionally complete and were based on theAIN-93 G diet (Reeves et al. 1993). All diets contained 20% of protein,15% of fat and 0.12% of cholesterol. Five diets were prepared thatdiffered only by the type of polysaccharide added, as follows:

[0077] Cellulose (CE) (control diet)

[0078] Beta-Trim (beta glucan) low viscosity (BT-LV)

[0079] Beta-Trim (beta glucan) high viscosity (BT-HV)

[0080] Hydroxypropyl methylcellulose (HPMC) low viscosity (HPMC-LV)

[0081] Hydroxypropyl methylcellulose (HPMC) high viscosity (HPMC-LV) Thecomposition of these diets is given in Table 1. TABLE 1 Composition ofdiets containing Cellulose, Beta-Glucan or HPMC for 1 kg of diet Cell-ulose Beta-glucan Bet-aglucan HPMC LV HPMC Diet (g) LV (g) HV (g) (g) HV(g) Cornstarch 347 272.3 287 347 347 Casein 200 195.6 193.6 200 200Dextrinized 115.2 115.2 115.2 115.2 115.2 cornstarch Sucrose 87.3 87.387.3 87.3 87.3 Corn oil 150 150 150 150 150 Cellulose 50 29.1 16.4 10 10Mineral mix 35 35 35 35 35 Vitamin mix 10 10 10 10 10 L-Cystine 3 3 3 33 Choline 2.5 2.5 2.5 2.5 2.5 bitartrique BHT* 0.014 0.014 0.014 0.0140.014 Cholesterol* 1.2 1.2 1.2 1.2 1.2 Beta trim 0 100 0 0 0 12%Beta-trim 0 0 100 0 0 20% HPMC K100 0 0 0 40 0 HPMC K4M 0 0 0 0 20 HPMC0 0 0 0 20 K15M

[0082] The HPMC formulations were prepared from different HPMC grades.The low viscosity HPMC was K100 and the high viscosity HPMC mixture was50% K15M and 50% K4M. At 25° C., two percent solutions of the differentHPMC grades have the following viscosities: K100 viscosity is 100 mPa·s;K4M viscosity is 4000 mPa·s; and K15M viscosity is 15,000 mPa·s.

[0083] The appropriate formulations have been determined according toprevious studies in the lab to examine the correlation between in vivoand in vitro viscosity (unpublished).

[0084] Two diets contained BetaTrim (Quaker Oats, Inc) as a beta-glucansource: a 12% BetaTrim diet (10% of diet) and a 20% BetaTrim diet (10%of diet). For these diets, the addition of BetaTrim increased the amountof carbohydrates and protein according to the composition of theBetaTrim (4.4% of protein and 74.4% of starch in 12% BetaTrim and 6.4%of protein and 60.0% of starch in 20% BetaTrim). So, in order tonormalize the nutritional content of these diets to match that of theAIN-93 G diet, we compensated by lowering the quantity of casein toobtain a final total of 20% of protein. Cornstarch was used to balancethe carbohydrate quantity, while sucrose and dextrinized cornstarchstayed the same.

[0085] Two diets contained HydroxyPropylMethylCellulose (HPMC),(METHOCEL, The Dow Chemical Company, Midland, Mich., USA) aspolysaccharide source (4% of diet). The amount of cornstarch and caseinfor these diets was held constant.

[0086] Cellulose was used in a control diet, instead of the BetaTrim orthe HPMC used in the test diets. However, cellulose was also added tothe test diets to make up for the lesser weight percentage of theBetaTrim and HPMC. The amount of cellulose added to 1000 g of the fourtest diets was determined by adding all the other constituents togetherexcept cellulose and subtracting this amount from 1000 g.

[0087] Tissue Collection

[0088] Rats were fasted overnight before being taken. The followingmorning, they were anesthetized with ether and blood samples for leptinassay were drawn by cardiac puncture into tubes containing EDTA. Plasmawas prepared and stored at −70° C.

[0089] The abdominal cavity was opened. The small intestine was removed,the contents were collected in tubes and kept on ice. Then epididymaland retroperitoneal fad pads were removed and weighed. Livers wereremoved, weighed, and two grams were collected for microsomespreparation. The remainder of the livers were wrapped in plastic bagsand quickly frozen for cholesterol measurement. The two femurs wereremoved, one for calcium content measurement and the other one for bonedensity measurement, and wrapped in plastic bags and frozen.

[0090] Plasma Leptin Level

[0091] Serum was stored at −70° C. until hormone assay was performed.Plasma leptin level was determined in duplicate by a commercialradioimmunoassay kit using ¹²⁵I-labeled rat leptin antiserum (LincoResearch, St Charles, Mo.).

[0092] Liver Cholesterol Analysis

[0093] Samples for liver cholesterol analysis were prepared according tothe method of Folch et al. (1957) for lipids extraction, modified andapplied to liver. Lipids were extracted from approximately 1 g (exactweight known) of liver. Samples were homogenized and rinsed withchloroform:methanol (2:1) (total 20 mL), filtered through a filterpaper, mixed with a 6 mL of 0.9% NaCl solution and centrifuged. Thelower phase was kept and evaporated under N₂. Samples were reconstitutedin 10 mL chloroform:methanol.

[0094] Cholesterol assay was performed on 10 uL using a commercial kit(Infinity™ cholesterol reagent, Sigma Diagnostics, St. Louis, Mo.).

[0095] Intestinal Content Supernatant Viscosity Measurement

[0096] After fasting overnight, animals were fed 7.5 g of diet andallowed 2½ hours for consumption and digestion. The precise amount ofdiet consumed was recorded. Once the small intestine removed, thecontents were stripped out in tubes and centrifuged at 30° C. and 19,500g for 45 minutes. Then, supernatant was collected and the viscosity of0.5 ml of sample was measured at 37° C. with a Brookfield-WellsConeplate viscometer, model LVT-CP (CP-51 cone). Measurements were takenat shear rates, then viscosity versus shear rate was plotted on alog-log scale and viscosity was estimated by extrapolation of the lineto a shear rate of 23.0 s⁻¹.

[0097] Bone Density Determination

[0098] The bone density was measured using the method of Archimedes'principle (Keenan et al. 1992, Keenan et al. 1997). The bones werecleaned and hydrated by immersion in distilled water under vacuum forone hour (bone is porous and air in bone must be displaced by immersionin distilled water). Bones were weighed twice with a microelectrobalance (Cahn), first out of water, and then submerged in water.The density was calculated using the formula:

P _(bone) =A/(A−B)*P _(w)

[0099] where P_(bone) is the density of the bone, P_(W) is the densityof distilled water at known temperature, A is the weight of the hydratedbone out of water, B is the weight of hydrated bone submerged in waterand A−B is the difference of weight equivalent to the weight of volumedisplaced by the bone, equivalent of the volume of the bone.

[0100] Bone Calcium Content

[0101] Calcium in bones was measured by atomic absorption analysis.Bones were ashed for 12 hours at 485° C. Ashes were diluted in 5 mL of20% trace metal free HCl, then 5 mL of distilled water. Supernatant wasremoved after ashes settled and diluted 1000 times with 0.5% lanthanumchloride. A Perkin-Elmer flame atomic absorption spectrometer was usedto analyze samples for calcium content.

[0102] Statistical Analysis

[0103] Values were expressed as means ± standard error. The significanceof differences was analyzed by one-way ANOVA performing PROC GLM in SASstatistical software (SAS Institute 1999). Duncan's multiple range testwas used to detect differences among the groups. A significantdifference was accepted at p<0.05.

Results

[0104] Intestinal Content Supernatant Viscosity

[0105] The intestinal contents supernatant viscosities are shown onTable 2. As can be seen, the BT-HV group's viscosity is much lower thanthe HPMC-HV diet's viscosity in spite of the attempt to match theirviscosities. The BT-LV, BT-HV, HPMC-LV, and HPMC-HV diets increasedsignificantly the intestinal viscosity compared to the cellulose andBT-LV diets (p<0.05). The viscosities of the two HPMC diets are notsignificantly different (p>0.05). TABLE 2 Final Body weight, Peritonealand Epididymal Fat Pads Weights, and % of fat pads in body weight ofrats fed diets cellulose, high and low viscosity Beta glucan and highand low viscosity HPMC Intest- ine Vis- Final % of fat cosity bodyRetroperitoneal Epidydimal pads in Dietary (mPa · weight fat pad fat padbody group s) (g) weight (g) weight (g) weight Cellulose   8.2^(a)313.00^(a) 2.35^(a) 2.17^(a) 2.87^(a) Beta  533.6^(b) 299.09^(ab)2.22^(ab) 2.06^(ab) 2.83^(a) glucan LV Beta  997.6^(b) 285.82^(b)1.64^(c) 1.65^(c) 2.28^(b) glucan HV HPMC 2082^(c) 300.91^(ab) 1.76^(bc)1.83^(abc) 2.36^(b) LV HPMC 2163.3^(c) 293.09^(ab) 1.51^(c) 1.73^(bc)2.19^(b) HV

[0106] Body Weight and Fat Pad Weights

[0107] The final body weights of the animals for the 5 different dietgroups are shown Table 2.

[0108] As illustrated by Table 2, there is no significant difference inbody weight except between cellulose and BT-HV groups (p<0.05). Therewere no significant differences in food intake among the five groups,although there was a trend for a lower food intake in the BT-HV group.

[0109] The % of fat pads is an index of the % of body fat mass. Table 2shows fat pads weights and the % of fat pads weight in body weight foreach diet group. Fat pad weight decreased when viscosity increased forthe two kinds of fat pads, although the effect is more apparent forretroperitoneal fat pads. The BT-LV diet did not have a significanteffect on the fat pads weight, but for the rats fed the two HPMC dietsthe fat pads weights are significantly lower (p=0.092 for epididymal fatpad and p=0.008 for retroperitoneal fat pad). The % of fat pads of bodyweight is an index of the % of body fat mass. This % is negativelycorrelated with viscosity (r²=0.73) (FIG. 1). The % of fat pads in bodyweight for the BT-HV, HPMC-LV, HPMC-HV diets fed animals representreductions of 20%, 18% and 24% of the % of fat pads weight in bodyweight compared to the cellulose diet.

[0110] Liver Cholesterol Concentration

[0111] Table 3 provides the liver cholesterol concentrations for each ofthe 5 diets, along with the intestinal viscosity, plasma leptinconcentrations, bone density and bone calcium concentrations. TABLE 3Intestine viscosity, Liver cholesterol concentration, plasma leptinconcentration corrected by body weight, bone density and bone calciumcontent in rats fed cellulose, Beta glucan low and high viscosity, andHPMC low and high viscosity diets Plasma Leptin Liver Concentration,Intestine Cholesterol corrected by body Bone Calcium Dietary ViscosityConcentration weight Bone Concentration group (mPa · s) (mg/g) (g)Density (mg/g) Cellulose 8.2^(a) 11.89^(a) 11.02^(a) 1.380^(a)230.17^(a) Beta- 533.6^(b) 8.10^(b) 12.68^(a) 1.391^(a) 240.01^(a)glucan LV Beta- 997.6^(b) 7.46^(b) 9.56^(ab) 1.380^(a) 233.54^(a) glucanHV HPMC- 2082.0^(c) 7.41^(b) 6.68^(b) 1.366^(ab) 221.65^(a) LV HPMC-2163.3^(c) 7.82^(b) 6.90^(b) 1.345^(b) 199.89^(b) HV

[0112] Values in the same column with different superscripts aresignificantly different (p<0.05).

[0113] For each of the BT or HPMC diet-fed groups, there was asignificant hypocholesterolemic effect in the liver compared to thecellulose diet-fed group (p=0.0001). However, between the two BTdiet-fed groups, the difference was not statistically significant, norwas the difference statistically significant between the two HPMCdiet-fed groups or between BT groups and HPMC groups.

[0114] Liver cholesterol concentration was highly correlated with thelog of intestinal contents supernatant viscosity (r²=95).

[0115] Plasma Leptin Concentration

[0116] As shown in Table 3, the plasma leptin concentration issignificantly reduced in the groups fed HPMC, and there was a trend fora reduction in the BT-HV group. A bar graph illustrating the plasmaleptin concentration for animals fed the different diets is provided inFIG. 6. Indeed, there was a high inverse correlation between plasmaleptin concentration and intestinal contents supernatant viscosity(r²=0.82) (FIG. 2), which was slightly reduced when plasma leptin valueswere statistically corrected for body weigh (r²=0.72) (FIG. 3).

[0117] Plasma leptin concentration was also highly correlated with the %of fat pads in body weight (r²=0.71) (FIG. 4). Similarly, plasma leptinconcentration was highly correlated with the % of epididynal fat pad inbody weight (r²=0.781) (FIG. 5). A bar graph illustrating the peritonealfat pad weight for animals fed the different diets is provided in FIG.7.

[0118] Bone Density and Calcium

[0119] Bone density (Table 3) was significantly lower for animals fedhigh viscosity HPMC diets compared to the animals fed the cellulose dietor the low or high BT diets. Bone density was also positively correlatedwith plasma leptin concentration (r²=0.75) (figure not shown).

[0120] The bone calcium concentration for the 5 groups is shown in Table3. The bone calcium concentration of the HPMC-HIV group wassignificantly lower than the other groups. The bone calcium content andbone density were highly correlated (r²=0.98), as expected (figure notshown).

[0121] These data indicate that the low viscosity HPMC diet may be thebest diet because this diet causes a decrease in percent body fat, lowerplasma cholesterol levels and lower leptin plasma concentrations withoutsignificant adverse effects on bone density. The high viscosity HPMCdiet also has beneficial effects but tends to have a negative effect onbone density. The lower HV HPMC bone density was not necessarily relatedto lower leptin concentrations because the LV HPMC diet gave rise toeven lower leptin concentration without such a negative bone densityeffect. The negative effect on bone density may therefore be counteredby calcium supplements.

[0122] The high viscosity beta-glucan diet also has positive effects onbody fat and cholesterol, as well as a positive effect on leptinconcentrations without much effect on bone density.

What is claimed:
 1. A method of reducing the percentage of body fat in amammal comprising administering a sufficient amount of viscous,water-soluble, non-nutritive, non-starch, indigestible polysaccharide tothe mammal for a time sufficient to reduce the percentage of body fat inthe mammal.
 2. The method of claim 1 wherein the polysaccharide is apolymer of monosaccharides substantially connected by beta (β)glycosidic linkages.
 3. The method of claim claim 2 wherein themonosaccharides are arabinose, fructose, glucose, glucosamine,glucuronic acid, galactose, galactosammine, mannose, N-acetylmuramicacid, N-acetylneuraminic acid, rhamnose, xylose or a mixture thereof. 4.The method of claim 2 wherein the beta glycosidic linkages are 1→2beta-glycosidic bonds, 1→3 beta-glycosidic bonds, 1→4 beta-glycosidicbonds, 1→6 beta-glycosidic or a mixture thereof.
 5. The method of claim2 wherein the beta glycosidic linkages are 1→3 beta glycosidic linkagesor 1→4 beta glycosidic linkages, or a mixture of 1→3 and 1→4beta-glycosidic linkages.
 6. The method of claim 1 wherein thepolysaccharide is locust bean gum, guar gum, carrageenan, alginate,modified cellulose, beta-glucan, or glucomannan.
 7. The method of claim1 wherein the polysaccharide has Formula I:

wherein each R is separately hydroxy, lower alkyloxy, or hydroxy(lower(alkyloxy)); n is an integer ranging from about 500 to about 2500;and X is an R group or a covalent bond to the oxygen at the firstposition of the adjacent monosaccharide.
 8. The method of claim 1wherein the polysaccharide is methylcellulose, hydroxypropylmethylcellulose, 2-hydroxypropyl methylcellulose, 2-hydroxyethylmethylcellulose, 2-hydroxybutyl methylcellulose, 2-hydroxyethylethylcellulose, 2-hydroxypropyl cellulose, methyl ethylcellulose, or2-hydroxyethylcellulose.
 9. The method of claim 1 wherein thepolysaccharide is β-glucan.
 10. The method of claim 1 wherein thepolysaccharide is hydroxypropyl methylcellulose.
 11. The method of claim1 wherein the sufficient amount of polysaccharide is an amount thatprovides an intestinal viscosity of about 1000 mPa·s to about 3000mPa·s.
 12. The method of claim 11 wherein the sufficient amount ofpolysaccharide is an amount that provides an intestinal viscosity ofabout 1500 mPa·s to about 2500 mPa·s.
 13. The method of claim 1 whereinthe sufficient amount of polysaccharide is about 1 g to about 5 gpolysaccharide per meal.
 14. The method of claim 1 wherein thesufficient amount of polysaccharide is about 2 g to about 3 gpolysaccharide per meal.
 15. The method of claim 1 wherein the timesufficient for reducing the percentage of body fat is at least about twoto at least about ten weeks.
 16. The method of claim 1 wherein the timesufficient for reducing the percentage of body fat is at least aboutthree weeks to at least about eight weeks.
 17. The method of claim 1wherein the time sufficient for reducing the percentage of body fat isat least about four to at least about six weeks.
 18. The method of claim1 wherein the polysaccharide is administered indefinitely.
 19. Themethod of claim 1 where the percentage of body fat is reduced by about5% to about 40%.
 20. The method of claim 1 where the percentage of bodyfat is reduced by about 10% to about 30%.
 21. The method of claim 1where the percentage of body fat is reduced by about 15% to about 25%.22. The method of claim 1 where the mammal is a human.
 23. The method ofclaim 1 where the polysaccharide is administered in an applesauce, acereal, a cookie, a cracker, a flavored drink, a fruit juice, an icecream, a milk shake, a pudding or a snack bar.
 24. A method of reducingthe percentage of body fat in a mammal comprising administering asufficient amount of beta-glucan to the mammal for a time sufficient toreduce the percentage of body fat in the mammal.
 25. The method of claim24 wherein the sufficient amount of beta-glucan is an amount thatprovides an intestinal viscosity of about 1000 mPa·s to about 3000mPa·s.
 26. The method of claim 24 wherein the sufficient amount ofbeta-glucan is an amount that provides an intestinal viscosity of about1500 mPa·s to about 2500 mPa·s.
 27. The method of claim 24 wherein thesufficient amount of beta-glucan is about 1 g to about 5 g beta-glucanper meal.
 28. The method of claim 24 wherein the sufficient amount ofbeta-glucan is about 2 g to about 3 g beta-glucan per meal.
 29. Themethod of claim 24 wherein the time sufficient for reducing thepercentage of body fat is at least about two to at least about tenweeks.
 30. The method of claim 24 wherein the time sufficient forreducing the percentage of body fat is at least about three weeks to atleast about eight weeks.
 31. The method of claim 24 wherein the timesufficient for reducing the percentage of body fat is at least aboutfour to at least about six weeks.
 32. The method of claim 24 wherein thebeta-glucan is administered indefinitely.
 33. The method of claim 24where the percentage of body fat is reduced by about 5% to about 40%.34. The method of claim 24 where the percentage of body fat is reducedby about 10% to about 30%.
 35. The method of claim 24 where thepercentage of body fat is reduced by about 15% to about 25%.
 36. Themethod of claim 24 where the mammal is a human.
 37. The method of claim24 where the beta-glucan is administered in an applesauce, a cereal, acookie, a cracker, a flavored drink, a fruit juice, an ice cream, a milkshake, a pudding or a snack bar.
 38. A method of reducing the percentageof body fat in a mammal comprising administering a sufficient amount ofhydroxypropyl methylcellulose to the mammal for a time sufficient toreduce the percentage of body fat in the mammal.
 39. The method of claim38 wherein the sufficient amount of hydroxypropyl methylcellulose is anamount that provides an intestinal viscosity of about 1000 mPa·s toabout 3000 mPa·s.
 40. The method of claim 38 wherein the sufficientamount of hydroxypropyl methylcellulose is an amount that provides anintestinal viscosity of about 1500 mPa·s to about 2500 mPa·s.
 41. Themethod of claim 38 wherein the sufficient amount of hydroxypropylmethylcellulose is about 1 g to about 5 g hydroxypropyl methylcelluloseper meal.
 42. The method of claim 38 wherein the sufficient amount ofhydroxypropyl methylcellulose is about 2 g to about 3 g hydroxypropylmethylcellulose per meal.
 43. The method of claim 38 wherein the timesufficient for reducing the percentage of body fat is at least about twoto at least about ten weeks.
 44. The method of claim 38 wherein the timesufficient for reducing the percentage of body fat is at least aboutthree weeks to at least about eight weeks.
 45. The method of claim 38wherein the time sufficient for reducing the percentage of body fat isat least about four to at least about six weeks.
 46. The method of claim38 wherein the hydroxypropyl methylcellulose is administeredindefinitely.
 47. The method of claim 38 where the percentage of bodyfat is reduced by about 5% to about 40%.
 48. The method of claim 38where the percentage of body fat is reduced by about 10% to about 30%.49. The method of claim 38 where the percentage of body fat is reducedby about 15% to about 25%.
 50. The method of claim 38 where the mammalis a human.
 51. The method of claim 38 where the hydroxypropylmethylcellulose is administered in an applesauce, a cereal, a cookie, acracker, a flavored drink, a fruit juice, an ice cream, a milk shake, apudding or a snack bar.
 52. A method of reducing the level of leptin inthe bloodstream of a mammal comprising administering a sufficient amountof viscous, water-soluble, non-nutritive, non-starch, indigestiblepolysaccharide to the mammal for a time sufficient to reduce the levelof leptin in the bloodstream of the mammal.
 53. The method of claim 52wherein the polysaccharide is a polymer of monosaccharides substantiallyconnected by beta (β) glycosidic linkages.
 54. The method of claim 53wherein the monosaccharides are arabinose, fructose, glucose,glucosamine, glucuronic acid, galactose, galactosammine, mannose,N-acetylmuramic acid, N-acetylneuraminic acid, rhamnose, xylose or amixture thereof.
 55. The method of claim 53 wherein the beta glycosidiclinkages are 1→2 beta-glycosidic bonds, 1→3 beta-glycosidic bonds, 1→4beta-glycosidic bonds, 1→6 beta-glycosidic or a mixture thereof.
 56. Themethod of claim 53 wherein the beta glycosidic linkages are 1→3 betaglycosidic linkages or 1→4 beta glycosidic linkages, or a mixture of 1→3and 1→4 beta-glycosidic linkages.
 57. The method of claim 52 wherein thepolysaccharide is locust bean gum, guar gum, carrageenan, alginate,modified cellulose, beta-glucan, or glucomannan.
 58. The method of claim52 wherein the polysaccharide has Formula I:

wherein each R is separately hydroxy, lower alkyloxy, or hydroxy(lower(alkyloxy)); n is an integer ranging from about 500 to about 2500;and X is an R group or a covalent bond to the oxygen at the firstposition of the adjacent monosaccharide.
 59. The method of claim 52wherein the polysaccharide is methylcellulose, hydroxypropylmethylcellulose, 2-hydroxypropyl methylcellulose, 2-hydroxyethylmethylcellulose, 2-hydroxybutyl methylcellulose, 2-hydroxyethylethylcellulose, 2-hydroxypropyl cellulose, methyl ethylcellulose, or2-hydroxyethylcellulose.
 60. The method of claim 52 wherein thepolysaccharide is β-glucan.
 61. The method of claim 52 wherein thepolysaccharide is hydroxypropyl methylcellulose.
 62. The method of claim52 wherein the sufficient amount of polysaccharide is an amount thatprovides an intestinal viscosity of about 1000 mPa·s to about 3000mPa·s.
 63. The method of claim 52 wherein the sufficient amount ofpolysaccharide is an amount that provides an intestinal viscosity ofabout 1500 mPa·s to about 2500 mPa·s.
 64. The method of claim 52 whereinthe sufficient amount of polysaccharide is about 1 g to about 5 gpolysaccharide per meal.
 65. The method of claim 52 wherein thesufficient amount of viscous polysaccharide is about 2 g to about 3 gpolysaccharide per meal.
 66. The method of claim 52 wherein the timesufficient for reducing the level of leptin in the bloodstream of amammal is at least about two to at least about ten weeks.
 67. The methodof claim 52 wherein the time sufficient for reducing the level of leptinin the bloodstream of a mammal is at least about three weeks to at leastabout eight weeks.
 68. The method of claim 52 wherein the timesufficient for reducing the level of leptin in the bloodstream of amammal is at least about four to at least about six weeks.
 69. Themethod of claim 52 wherein the polysaccharide is administeredindefinitely.
 70. The method of claim 52 where the level of leptin inthe bloodstream of a mammal is reduced by about 5% to about 50%.
 71. Themethod of claim 52 where the level of leptin in the bloodstream of amammal is reduced by about 10% to about 40%.
 72. The method of claim 52where the level of leptin in the bloodstream of a mammal is reduced byabout 15% to about 35%.
 73. The method of claim 52 where the mammal is ahuman.
 74. The method of claim 52 where the polysaccharide isadministered in an applesauce, a cereal, a cookie, a cracker, a flavoreddrink, a fruit juice, an ice cream, a milk shake, a pudding or a snackbar.
 75. A composition for lowering the percentage of body fat in amammal comprising about 1 g to about 5 g of viscous, water-soluble,non-nutritive, non-starch, indigestible polysaccharide, wherein saidcomposition can lower the percentage of body fat when administered abouttwo to three times per day for about at least about two to at leastabout ten weeks.
 76. The composition of claim 75 containing about 1.5 gto about 4 g of the polysaccharide.
 77. The composition of claim 75containing about 2 g to about 3 g of the polysaccharide.
 78. Thecomposition of claim 75 wherein the polysaccharide is a polymer ofmonosaccharides substantially connected by beta (β) glycosidic linkages.79. The composition of claim 78 wherein the monosaccharides arearabinose, fructose, glucose, glucosamine, glucuronic acid, galactose,galactosammine, mannose, N-acetylmuramic acid, N-acetylneuraminic acid,rhamnose, xylose or a mixture thereof.
 80. The composition of claim 78wherein the beta glycosidic linkages are 1→2 beta-glycosidic bonds, 1→3beta-glycosidic bonds, 1→4 beta-glycosidic bonds, 1→6 beta-glycosidic ora mixture thereof.
 81. The composition of claim 78 wherein the betaglycosidic linkages are 1→3 beta glycosidic linkages or 1→4 betaglycosidic linkages, or a mixture of 1→3 and 1→4 beta-glycosidiclinkages.
 82. The composition of claim 75 wherein the polysaccharide islocust bean gum, guar gum, carrageenan, alginate, modified cellulose,beta-glucan, or glucomannan.
 83. The composition of claim 75 wherein thepolysaccharide has Formula I:

wherein each R is separately hydroxy, lower alkyloxy, or hydroxy(lower(alkyloxy)); n is an integer ranging from about 500 to about 2500;and X is an R group or a covalent bond to the oxygen at the firstposition of the adjacent monosaccharide.
 84. The composition of claim 75wherein the polysaccharide is methylcellulose, hydroxypropylmethylcellulose, 2-hydroxypropyl methylcellulose, 2-hydroxyethylmethylcellulose, 2-hydroxybutyl methylcellulose, 2-hydroxyethylethylcellulose, 2-hydroxypropyl cellulose, methyl ethylcellulose, or2-hydroxyethylcellulose.
 85. The composition of claim 75 wherein thepolysaccharide is β-glucan.
 86. The composition of claim 75 wherein thepolysaccharide is hydroxypropyl methylcellulose.
 87. The composition ofclaim 75 wherein the composition provides an intestinal viscosity ofabout 1000 mPa·s to about 3000 mPa·s.
 88. The composition of claim 75wherein the composition provides an intestinal viscosity of about 1500mPa·s to about 2500 mPa·s.
 89. The composition of claim 75 wherein thepercentage of body fat is reduced in at least about three weeks to atleast about eight weeks.
 90. The composition of claim 75 wherein thepercentage of body fat is reduced in at least about four weeks to atleast about six weeks.
 91. The composition of claim 75 wherein thecomposition is administered indefinitely.
 92. The composition of claim75 where the percentage of body fat is reduced by about 5% to about 40%.93. The composition of claim 75 where the percentage of body fat isreduced by about 10% to about 30%.
 94. The composition of claim 75 wherethe percentage of body fat is reduced by about 15% to about 25%.
 95. Thecomposition of claim 75 where the mammal is a human.
 96. The compositionof claim 75 incorporated into an applesauce, a cereal, a cookie, acracker, a flavored drink, a fruit juice, an ice cream, a milk shake, apudding or a snack bar.